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NABP e-News November 15, 2006
FDA Releases CPG and Q&A on Implementation of PDMA Pedigree Rule
Food and Drug Administration on November 13 released a compliance policy guide (CPG) to clarify its strategy for prioritizing enforcement of pedigree requirements outlined in the Prescription Drug Marketing Act of 1987 (PDMA). After several delays due to stakeholder concerns, the pedigree requirements outlined in the 1999 “Final Rule” of the PDMA will take effect on December 1. In conjunction with the CPG, the agency also released Guidance for Industry: Prescription Drug Marketing Act (PDMA) Requirements, Questions and Answers, which provides further information and recommendations on the pedigree rule. NABP is in the process of evaluating both documents to determine their potential impact on previous and ongoing state efforts to implement pedigree systems, as well as the impact on pharmacy practice. More information on this issue will be forthcoming. Both documents are available at http://www.accessdata.fda.gov/scripts/oc/ohrms/advdisplay.cfm.
NABP Launches Enhanced, Expanded Web Site Today
NABP launched its newly redesigned Web site today. The new site provides more information in an easier-to-use format to better assist boards of pharmacy in the development, implementation and enforcement of pharmacy standards. The home page provides a forum for frequent updates on pharmacy regulatory news. The top menu leads to the familiar standbys, as well as to new sections such as Counterfeit Drug Information, complete with podcasts of expert commentary. The left menu provides a virtual filing cabinet of licensure and accreditation resources. Other enhancements include a site map and a Google™ search feature to help visitors find the information they need quickly and easily, and a text-sizing option to let visitors control the text size for easier viewing. The site is accessible at http://www.nabp.net.
New Congress Weighs Decreasing Drug Costs, Increasing Safety Measures
Decreasing prescription drug costs and increasing safety measures are just a sampling of the shifting priorities rumored to be on the horizon, with a Democratic majority now in control of the House. Reports indicate that Democrats plan to use federal buying power to drive down the cost of prescription medicines. The shift in power puts more weight behind the Democratic push for allowing Medicare to negotiate drug prices directly with manufacturers, as well as for Congress to implement price control measures. Stock prices declined for drug companies, health insurers, and pharmacy benefit firms in the days following the election. In addition, Rep. Henry Waxman (D-CA), the incoming chair of the House Government Reform Committee, is rumored to be considering drafting a drug safety bill.
International Anti-counterfeiting Taskforce Convenes Today
Today marks the first meeting of the International Medical Products Anti-counterfeiting Taskforce (IMPACT). Established by the World Health Organization (WHO) and its partners, the global taskforce includes members of WHO, the International Federation of Pharmaceutical Manufacturers Associations, the World Trade Organization, and other stakeholders. WHO announced that, during this pilot meeting held in Bonn, Germany, the taskforce would unveil a global plan to combat counterfeiting, focusing on five key areas: legislative and regulatory infrastructure, regulatory implementation, enforcement, technology, and communication. WHO said the taskforce plans to release the most recent estimates of the number of counterfeit drugs in circulation, launch pilot programs in three countries, and introduce a plan to strengthen national policies on counterfeiting. More information is available at http://www.who.int/medicines/services/counterfeit/en/index.html.
